MODIFICATION
A -- Preclinical PREVENT Cancer Program-Toxicology and Pharmacology Testing
- Notice Date
- 1/28/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-PRESOL-TSB-5009-04
- Archive Date
- 3/31/2015
- Point of Contact
- DAWN M ALBERTINI, Phone: 3016248760, C. Timothy Crilley, Phone: 301-624-8743
- E-Mail Address
-
Dawn.Albertini@nih.gov, tcrilley@mail.nih.gov
(Dawn.Albertini@nih.gov, tcrilley@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- FEDERAL BUSINESS OPPORTUNTIES SOLICIATION NOTICE RFP - N01CN45009-45 Contracting Office Address Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, 8490 Progress Drive, Suite 400, Room 4041, Frederick, Maryland 21701. Note: This Solicitation follows a Sources Sought notice that was released on July 24, 2014 under HHSN-NIH-NCI-SBSS-PCPSB-45009-45; A Pre-Solicitation notice was released on January 5, 2015 under HHS-NIH-NCI-PRESOL-TSB-5009-04. Description The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) is planning to award multiple contracts under the Preclinical PREVENT Cancer Program: Toxicology and Pharmacology Testing. These contracts will support the conduct of toxicological and pharmacological evaluations of potential cancer preventive agents for Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for phase 0, 1-3 clinical studies, New Drug Applications (NDA) to the FDA, and to selection appropriate first-in-human (FIH) doses. The contracts will require the Contractors to perform studies in four areas: genotoxicity testing; general toxicology in experimental animals; reproductive toxicology studies in rodents and rabbits; and, specialized studies. The Successful Contractor shall be able to perform work in these Task Areas as outlined in each Task Order: TASK AREA 1 -- GENOTOXICITY TESTING The Contractor shall determine the homogeneity, concentration, and stability of the test substance/ test substance mixture under the conditions of use, as defined in the Task Order Statement of Work (TO SOW). A. Bacterial reverse mutation test B. An in vitro test with cytogenetic evaluation of chromosomal damage with mammalian cells C. An in vivo test for chromosomal damage using mouse or rat hematopoietic cells D. Follow-up strategies for positive tests TASK AREA 2 -- GENERAL TOXICOLOGY IN EXPERIMENTAL ANIMALS The Contractor shall conduct studies in mice, rats and dogs. However, on rare occasions the Contractor shall use other species such as rabbits, guinea pigs, hamsters, monkeys or other animals that are deemed more appropriate due to the inherent nature of the chemopreventive agent. A. Fourteen-day dose ranging oral toxicity in rodents B. Twenty-eight day studies in rodents and dogs C. Ninety day, oral toxicity studies in rodents and dogs D. Six month rodent and nine month dog chronic toxicity studies E. Carcinogenicity studies in rodents TASK AREA 3 -- REPRODUCTIVE TOXICITY STUDIES IN RODENTS AND RABBITS The Contractor shall conduct studies in this Task Area using mice, rats and rabbits. However, the Contractor shall use other species when appropriate due to the inherent nature of the chemopreventive agent or a suggestion by the regulatory agencies, and could include guinea pigs, hamsters, monkeys or other animals. A. Segment ii teratogenicity studies B. Two generation reproduction studies in rodents TASK AREA 4 -- SPECIALIZED STUDIES The Contractor shall conduct studies in this Task Area using mice, rats, dogs, rabbits, guinea pigs, hamsters, monkeys or other appropriate species to evaluate drug-specific mechanisms of toxicity. Interspecies differences in drug metabolism, pharmacokinetics, and pharmacodynamics are well recognized and shall be considered in the development of protocols. A. Bioanalytical methodology studies B. Pharmacokinetic and pharmacokinetic-pharmacodynamic studies C. Pioavailability and bioequivalence studies D. Drug metabolism/drug interaction studies E. Specific safety studies F. Genomics/proteomics/metabolomics G. Computational (predictive) pharmacology/toxicology H. Vaccine development studies In addition to the Task Areas, the animal facility of the successful Contractor shall be accredited or registered as follows: 1. Animal Facility: a) Office of Laboratory Animal Welfare (OLAW) (http://grants.nih.gov/grants/olaw/olaw.htm), b) Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) http://www.aaalac.org/accreditation/. c) Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm) and Guide for the Care and Use of Laboratory Animals http://www.nap.edu/catalog.php?version=b&utm_expid=4418042-5.krRTDpXJQISoXLpdo1Ynw.1&record_id=12910&utm_referrer=http%3A%2F%2Fgrants.nih.gov%2Fgrants%2Folaw%2Folaw.htm ) d) The United States Department of Agriculture (USDA). http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare e) Institutional Animal Care and Use Committee (IACUC) The following Mandatory Qualification Criteria apply to this requirement: The qualification criterion establishes conditions that must be met at the time of receipt of Proposals by the Contracting Officer's Representative and the Contracting Officer, in order for your proposal to be considered any further for award. 1) Demonstration of compliance to perform studies in accordance with the Food and Drug Administration (FDA) Good Laboratory Practice Regulations (GLP) as published in the CFR Title 21, Part 58 and as updated. Compliance shall be documented with the two most recent FDA inspection reports. 2) Current Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) (or equivalent) accreditation. 3) National Regulatory Commission licensure for use of radioactive materials and presence of organizational unit monitoring safe use and disposal. 4) Documented participation of an American College of Laboratory Animal Medicine (ACLAM) certified veterinarian It is anticipated that multiple Indefinite Delivery Indefinite Quantity (IDIQ) type contracts will be awarded for a 3-year period of performance beginning on or about September 15, 2015. Request for Proposal Number RFP - N01CN45009-45 may be accessed through the FedBizOpps website and the National Cancer Institute home page at http://rcb.cancer.gov/rcb-internet/index.jsp The NAICS Code is 541711. All responsible sources may submit a proposal which shall be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND ANY POSSIBLE AMENDMENTS. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF CONTRACT HEREIN. Point of Contact Dawn Albertini, Contracting Officer, Phone (301) 624-8760 - Dawn.Albertini@nih.gov Alternate Point of Contact Tim Crilley, Contracting Officer, Team Lead, Phone (301) 624-8743 - Tcrilley@mail.nih.gov Contracting Office: National Cancer Institute Treatment Support Branch Riverside 5 8490 Progress Drive, Suite 400 Frederick Maryland 21701
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/HHS-NIH-NCI-PRESOL-TSB-5009-04/listing.html)
- Record
- SN03626801-W 20150130/150128235028-7769902e197359555332efdd360fc9d6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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